Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery

NCT02046135 | Terminated Phase 2 Results DMC

• 1 other identifier: 13-007B
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The investigators hypothesize that the occurrence of acute kidney injury will be less in children treated with sodium bicarbonate in the perioperative period when compared to placebo. The specific aims of this proposal are as follows: 1\. To institute a prospective, randomized, double-blinded, placebo-controlled trial in pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.

Conditions

Acute Kidney Injury; Congenital Heart Disease

Keywords

Pediatric; Sodium bicarbonate; Acute kidney injury; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury

  The number of patients who developed AKI in each arm of the study. AKI was measured by the Pediatric Risk, Failure, Loss of Function, and End-Stage Renal Disease (pRIFLE) criteria or an absolute increase in creatinine of 0.3mg/dl.

  7 days

Secondary Outcomes (4)

• Cumulative Fluid Balance

  6 days

• Hospital and Intensive Care Unit Length of Stay

  1 month

• Need for Dialysis

  1 month

• Length of Mechanical Ventilation

  1 month

Study Arms (2)

Sodium bicarbonate

EXPERIMENTAL

At the start of the surgery, the patient will receive NaHCO3 as a continuous infusion of D5% 1/3NS + 100 meq/L NaHCO3 + 20 meq/L KCl at maintenance IVF (solution contains \~154 meq of sodium which is equivalent to normal saline). The NaHCO3 infusion will continue for the first 24 hours after the discontinuation of CPB. After 24 hours of receiving the NaHCO3 infusion, the IVF administered to the patient will be the standard solutions used in the PICU at CCMC.

Drug: Sodium Bicarbonate

Sodium Chloride

ACTIVE COMPARATOR

At the start of surgery, patients in the control arm will receive D5% Normal Saline + 20 meq/L KCl at maintenance IVF. After 24 hours, standard IVF, not containing NaHCO3 or Na acetate will be administered for the duration of the PICU stay as required, determined by the clinicians primarily caring for the patient postoperatively.

Drug: Sodium Chloride

Interventions

Sodium Bicarbonate DRUG

Sodium bicarbonate

Sodium Chloride DRUG

Sodium Chloride

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects age ≤18 years
• Subjects scheduled for cardiac surgery with cardiopulmonary bypass

You may not qualify if:

• Subjects with abnormal creatinine clearance (\<90 ml/min/1.7m2) as measured by the Schwartz formula
• Subjects with known cystic kidney disease or posterior ureteral valves (subjects with solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be excluded if renal function is preserved)
• Subjects with known metabolic disorder
• Premature infants born \<30 weeks gestation and \<30 days old due to risk of intraventricular hemorrhage
• Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Heart Defects, Congenital

Interventions

Sodium Bicarbonate; Sodium Chloride

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds

Limitations and Caveats

Early termination leading to small number of subjects analyzed. This may lead to unreliable or uninterpretable data.

Results Point of Contact

• Title: Dr. James Schneider
• Organization: Cohen Children's Medical Center

jschneide2@northwell.edu

7184703330

Study Officials

• James Schneider, MD

  Cohen Children's Medical Center of New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellowship Director Critical Care

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 27, 2014
• Study Start: September 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: July 22, 2017
• Last Updated: November 2, 2022
• Results First Posted: December 28, 2020

Record last verified: 2022-10

Locations

US (1)